Clinical trial · Interventional
The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients
The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Patients With Cancer Treated With Oxaliplatin-fluorouracil Chemotherapy Protocols
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oxaliplatin(OXA) chemotherapy protocols are used in treatment of cancers like colorectal (CRC) and pancreatic cancer. OXA causes peripheral neuropathy which is considered treatment limiting factor. In recent studies, it shows that omeprazole(OME) has antioxidant effect and can inhibit organic cation transporter 2 (OCT2) in kidney. So OME can protect against peripheral neuropathy induced by OXA through oxidative stress . Also OME activates extracellular-signal-regulated kinase(ERK) / mitogen activated protein kinase ( MAPK) pathway, so improves demyelinating symptoms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Control grp will not receive omeprazole . They will receive chemotherapy protocols only
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Intervention group will receive omeprazole plus chemotherapy protocols
- interventionNames
- Drug: Omeprazole
Primary outcomes (2)
- measure
- Acute peripheral neuropathy
- timeFrame
- After the first intervention by 2 weeks of the first chemotherapy cycle ( each cycle is two days every two weeks), and through the study average for six months
- description
- the percentage of patients with acute peripheral sensory neuropathy grade ≥ 2 and the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and pain rating scale score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Recently diagnose cases with colorectal (CRC)and pancreatic cancers (males and females) ≥ 18 years old, and ≤ 65 years old. * Patients who will scheduled to receive modified FOLFOX-4,6,7 (OXA, Leucovorin, and 5-fluorouracil) or mFOLFIRINOX (OXA, irinotecan,leucovorin, and 5-Fluorouracil) for 12 cycles. * Patients with performance status 0-2 according to Eastern Cooperative Oncology Group (ECOG) Score. Exclusion Criteria: * Evidence of pre-existing peripheral neuropathy resulting from another reason (documented patients with brain tumor, brain trauma, seizures or any other neuropathic disorder). * CRC patients receiving protocols containing capecitabine. * Diabetic patients. * Documented Patients with lupus (SLE), or any other autoimmune disease. * Documented Patients with osteoporosis or fractures. * Prior exposure to neurotoxic chemotherapy for at least 6 months prior to the study. * Concomitant use of other neuroprotective medications (gabapentin, lamotrigine, phenytoin, tricyclic antidepressants, etc.,). * Patients taking medications that omeprazole can interact with or affect their metabolism, such as (digoxin, ketoconazole, methotrexate, clopidogrel, marevan, etc.,). * Pregnant and breastfeeding women. * Patients with abnormal renal function (S.cr \> 1.5 mg/dl or crcl \< 45 ml/min). * Patients with liver diseases (serum bilirubin \> 1.5 mg/dl / Alanine transaminase, Aspartate transaminase \> 2-4 ULN). * Smokers or documented patients with condition associated with oxidative stress.
References
Publications (0)
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